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Drug Maker Fails to Cooperate

According to federal investigators, the Congressional investigation into the recent recall of children’s Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson. This raises the prospect that new measures — like issuing subpoenas to compel cooperation — will now be invoked. McNeil Consumer Healthcare, the unit of Johnson & Johnson that makes the over-the-counter drugs, is now under scrutiny by the FDA for a pattern of violations in manufacturing and quality control practices that have led to a number of recent recalls.

The FDA has indicated as far back as May that it was considering criminal penalties or other actions against McNeil. Rep. Edolphus Towns, a New York Democrat, and chairman of the House Committee on Oversight and Government Reform, says Johnson & Johnson has used delaying tactics in its dealings with the committee and in some instances had provided misinformation. It’s not too surprising that the company denies these accusations. Congress should make sure Johnson & Johnson complies with all requests and the committee should be very aggressive as it looks into drug quality and safety issues raised by the recall.

The House committee opened its investigation in early May shortly after McNeil announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec. The products, made at a company plant in Fort Washington, Pennsylvania, may have included metal particles, or too much of the active drug ingredient, or inactive ingredients that did not meet testing standards. The FDA has referred the McNeil case to its office of criminal investigation, the agency’s law enforcement arm, which works with the Justice Department to prosecute companies accused of violating the laws governing drug manufacturing and marketing. It will be most interesting to see how the matter winds up.

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